SCANLAN® In Situ Valvulotomes

FDA UDI

Class II (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name: SCANLAN® In Situ Valvulotomes FDA UDI
Generic Name: Valvulotome FDA UDI
Device Name: In Situ Valvulotome cutting edge FDA UDI
Model / Reference: 9009-121 FDA UDI
Description: In Situ Valvulotome cutting edge FDA UDI

Identifiers

Catalog Number: 9009-121 FDA UDI
Primary DI / UDI-DI: 00846159010978 FDA UDI
FDA Product Code: MGZ FDA UDI
GMDN Term: Valvulotome FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4885 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Valvulotome

SCANLAN® In Situ Valvulotomes by Scanlan International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Valvulotome.

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PILLING — TELEFLEX INCORPORATED · Class I
PILLING — TELEFLEX INCORPORATED · Class I
Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc. · Class II
Over-the-Wire LeMaitre Valvulotome — LeMaitre Vascular, Inc. · Class II
V. Mueller — STERIS CORPORATION · Class I
Symmetry Surgical — SYMMETRY SURGICAL INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Scanlan International Inc

Sources (1)

FDA UDI c4b34b9a-ec58-47ef-8082-6368afc4002c 35 fields · synced May 30, 2026